DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

NCT02318706 | Completed Phase 3 Results

• 1 other identifier: DS5565-A-J303
• Study Type: interventional
• Target: 854
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain

  Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.

  Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])

Secondary Outcomes (1)

• Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain

  From baseline (Week 14) to Week 66

Study Arms (4)

placebo

PLACEBO COMPARATOR

placebo group (14 weeks)

Drug: placebo

DS-5565 15mg

EXPERIMENTAL

DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Drug: DS-5565

DS-5565 20 mg group

EXPERIMENTAL

DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose

Drug: DS-5565

DS-5565 30 mg group

EXPERIMENTAL

DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Drug: DS-5565

Interventions

DS-5565 DRUG

Also known as: mirogabalin

DS-5565 15mg; DS-5565 20 mg group; DS-5565 30 mg group

placebo DRUG

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or type 2 diabetes mellitus at screening
• Painful distal symmetric polyneuropathy
• At screening, a pain scale of ≥ 40 mm

You may not qualify if:

• HbA1c (National Glycohemoglobin Standardization Program) \> 10.0%

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead
• CMIC Co, Ltd. Japan: collaborator
• Quintiles, Inc.: collaborator
• Quintiles Malaysia Sdn Bhd: collaborator

Study Sites (1)

Saiki Central Hospital

Ōita, 876-0851, Japan

Location

Related Publications (1)

• Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29.

  PMID: 34059327 DERIVED

MeSH Terms

Interventions

mirogabalin

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo, Inc.

CTRinfo@dsi.com

1-908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 17, 2014
• Study Start: January 1, 2015
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: November 2, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (1)